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A Randomized, Double-Blind (Sponsor-unblinded), Placebo-Controlled, Adaptive Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK3640254 in HIV-1 Infected Treatment-Naïve Adults

Trial Profile

A Randomized, Double-Blind (Sponsor-unblinded), Placebo-Controlled, Adaptive Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK3640254 in HIV-1 Infected Treatment-Naïve Adults

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Sep 2023

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At a glance

  • Drugs Fipravirimat (Primary)
  • Indications HIV-1 infections
  • Focus Pharmacodynamics; Proof of concept
  • Sponsors ViiV Healthcare

Most Recent Events

  • 06 Jan 2022 Results assessing the antiviral effect, safety, tolerability, and PK of once-daily GSK3640254 monotherapy administered with food (moderate-fat meal) in HIV-1 positive, treatment-naive adults, published in the Clinical Infectious Diseases.
  • 10 Mar 2021 Results presented at the 28th Conference on Retroviruses and Opportunistic Infections
  • 09 Mar 2021 According to a ViiV Healthcare Media Release, a planned interim analysis showed treatment emergent resistance associated mutations in the 200 mg arm after dosing was complete.

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